Quality Management Systems (QMS) Coordinator
Care Access Research
Quality Assurance
United States · Remote
Posted on Nov 1, 2024
What We Do
Care Access is a unique, multi-specialty network of research sites which operates as one connected team of physician investigators, nurse coordinators, and operations managers. Our goal is to engage every healthcare professional in clinical research and to make clinical trials a care option for every patient. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies.
Who We Are
We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.
Position Overview
The Quality Management Systems (QMS) Coordinator will be responsible for the effective management and continuous improvement of the QMS within the organization. This role includes ensuring the QMS is up-to-date, performing system administration duties, troubleshooting for staff, and overseeing document control processes. The QMS Coordinator will facilitate communication of document releases and coordinate staff training. A key function of this role will be to also design, build and modify QMS workflows for the QMS modules.
What You'll Be Working On (Duties include but are not limited to):
- Key Responsibilities:
- Ensure the QMS is kept up-to-date at all times by driving the update for policies, procedures, and templates as required.
- Monitor QMS timelines for each QMS module (Documents, Issue Management, CAPA Management).
- Perform systems administration duties such as user management, troubleshooting system issues, and providing technical support to staff.
- Regularly monitor the QMS to ensure its effectiveness and compliance with regulatory standards (ISO 9001 and GCP).
- Design, build and modify QMS workflows for processes controlled by the eQMS.
- Manage document control activities supporting with the release of documents within the QMS.
- Ensure version control of documents, maintaining records of document changes and ensuring outdated versions are appropriately archived.
- Coordinate the release of new documents into the QMS, ensuring proper approval processes are followed.
- Facilitate communication with staff when new documents or processes are released into the QMS, liaising with the Learning and Development team to ensure training tasks based on role-specific training requirements.
- Maintain and update the QMS training matrix.
- Provide support and guidance to staff on QMS-related training requirements.
- Compile regular reports on the status health and performance of the QMS.
- Prepare QMS metrics from the QMS for the Operational Compliance Team.
QMS Maintenance and Administration:
Document Control:
Training Coordination:
Reporting and Monitoring:
Physical and Travel Requirements
- This is a remote position with less than 10% travel requirements.
What You Bring (Knowledge, Skills, and Abilities):
- Extensive experience with electronic Quality Management Systems in a highly regulated environment
- Extensive experience of ISO standards and Good Clinical Practice
- Strong Communication and project coordination skills
- Proficient in QMS software platforms and system troubleshooting
- Attention to detail and strong analytical problem solving skills
- Ability to work independently whilst collaborating with cross functional teams
- Proficient in Microsoft Office Suite
Certifications/Licenses, Education, and Experience:
- Bachelor's degree in a relevant field or equivalent experience (Life Sciences, Healthcare, or related discipline).
Benefits (US Full-Time Employees Only)
- PTO/vacation days, sick days, holidays.
- 100% paid medical, dental, and vision Insurance. 75% for dependents
- HSA plan
- Short-term disability, long-term disability, and life Insurance
- Culture of growth and equality
- 401k retirement plan
Diversity & Inclusion
We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success. At Care Access, every day, we are advancing medical breakthroughs. We’re uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the best physicians and caring for patients.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
Employment Statement
Care Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.
